Catherine Kenny

Ever wondered how a company navigates the complexities of Pharmacovigilance (PV)? Catherine Kenny, managing partner and co-founder of Signal Pharma Experts, takes us on an enlightening journey through it all. With years of experience spanning from a generics company to a director and head of Benefit Risk at Diamond Pharma Services, Catherine shares her invaluable insights into the intriguing world of PV.

Does the prospect of smaller firms utilizing AI, in the face of budgetary and resource limitations, seem daunting to you? Let’s take a look at it from a different angle. Imagine these firms joining forces to tackle larger safety database vendors - interesting, isn't it? Our discussion with Catherine brings in unique perspectives about managing regulatory inspections, project planning, and documentation. Plus, we emphasize on the oft-overlooked yet vital aspect of team spirit between departments in smaller firms. 

Catherine unveils the realities of running a risk management department in a small company, underscoring the indispensability of real-world data, risk minimization, and signal detection. So buckle up for a thought-provoking conversation that uncovers a spectrum of insights into the world of PV.

Transcript

Speaker 1 0:18

Welcome to another episode of Innovation and the Future of Farm Convigilance, a podcast series brought to you by Trudiant Talks. I'm your host, indy Alawalia, and I'm delighted to navigate the dynamic world of farm covigilance and risk management with you. But first a quick disclaimer the opinions expressed in this episode are solely of those of the individual guests and do not necessarily reflect the views of Trudiant Consulting. We're all about fostering insightful conversations here at Trudiant Talks and we want you to know that any product, vendor or service mentioned does not imply an endorsement. If you're seeking professional advice for specific situations, we encourage you to go to our experts. Please remember this podcast content is meant for informational and educational purposes only. Okay, so today we are incredibly fortunate to have the wonderful Katherine Kenney, the managing partner and co-founder of Signal Farmer Experts, as our guest speaker. Katherine hello.

Speaker 2 1:19

Hey Indy, how are you?

Speaker 1 1:20

I'm good. I'm good, how are you?

Speaker 2 1:22

I'm good, I'm good.

Speaker 1 1:26

I'm glad you're happy. So for those who are uninitiated, maybe you can give a summary of your experience in PV In actual fact, more importantly, how did you get into PV?

Speaker 2 1:42

Like everyone in PV, I fell into PV, so I don't think there's that many people who would have been a young child dreaming of working in pharmacovigilance. Maybe I'm wrong, but I'm not sure that that's a pathway that a lot of children are dreaming of. No, I studied science general sciences in university so quite broad and then I went off travelling, came back, did a bit of this, that and the other and then thought you know what, maybe it's about time I put my science background to use. At the time in Dublin there was a big presence from a lot of the main CROs. Quintiles now IQVIA had a big hub in Dublin and they were always recruiting science graduates. So that's how I got into PV. I joined Quintiles and I worked in drug safety for a number of years within the Dublin office, which was great. It was a real introduction to the world of safety. I worked on clinical trials a lot of the big pharma companies across multiple programmes, global trials, so it was really fast paced, really hectic, great team in the Dublin office and a lot of those people are still there. It's a really good training ground for a lot of pharmacovigilance professionals Within Ireland especially. There's not many people in pharmacovigilance within Ireland who haven't gone through Quintiles at some point, so it's quite a small pool of people that we all know each other.

Speaker 2 3:28

So I started off in IQVIA working in clinical trials and then I moved into pharma. So I worked in a generics company who had recently set up an Irish office. They were a UK-based company and they set up a Dublin office as well and I went and joined that company. We had quite a big portfolio of generic products and we were the pharmacovigilance global team for that company. So we did everything. So essentially went in and started your case processing, signal detection, literature, rmp, everything. So you're doing a bit of everything across the board, right the way through to the safety variation side of things, so working on the safety variation package that would be submitted, so working really tightly with the regulatory affairs team. And again, that was a really nice broad learning experience.

Speaker 2 4:33

So, moving into the post-marketing field from working in clinical, it gave me a really good understanding of, okay, how are we doing things on the other side of the fence when we have products that are actually out on the market? And with generics companies they are sensitive to cost. So usually you are quite stretched in terms of resources and you're always doing pretty much everything that you need to do within the PV operational side of things. So we had limited support in terms of external vendors. Everything was kind of managed in-house.

Speaker 2 5:08

And then went and worked in another generics company, a big South African company called Aspen, and again they had a presence in Dublin and a huge PV department. So we had about 50 people in the PV department. So really big team of people and again doing everything. So we were the global PV office for the whole company globally and we worked across about 40, 45 products, all of them with global licenses. So a lot of work, a lot of acquisitions in terms of products. So we were always adding to the portfolio. So there was data migrations that had to be taken into account, along with just managing back the day-to-day of about 40 different products.

Speaker 2 5:56

So very busy. I worked within the scientists team so I managed a team of scientists who were working on the safety kind of writing side of things, so do the signal management, psu, wars, aggregate reports, literature, et cetera. So again really fast-paced, really busy Right in terms of educating on all of the aspects of PV. And we did ask them. We had another team, so again we kind of did some of the work that maybe traditionally would sit within Reg Affairs, but we kind of took it into our team in terms of CCDS management, writing clinical overviews, rolling out those CCDSs and safety variations. So we did a lot of that work as well. So, again, busy.

Speaker 2 6:46

I've never worked in a company where we had the luxury of having different silos and somebody is just doing this one particular job. It's always been your PV, you do everything and it's always been quite a busy world within those global PV departments for those kinds of companies. Then I went off and I moved into consulting. So the end of 2017, myself and my colleague we joined forces and set up our own consulting company and we worked doing various different types of activities. I did some QPV consulting and we worked on scientific writing, risk management plans, safety reports, signal detection, that kind of thing Before I moved to Diamond Pharmacervices as a director and head of the Benefit Risk team in 2020. That was a consulting group. We managed quite a lot of different companies and clients. I was QPV for quite a number of clients. Usually, most of them were quite small companies with limited resources internally and that's why they outsourced to us.

Speaker 2 8:08

Being a contract QPV is quite challenging. So it's depending on the company. Everything every company is different and how they view the QPV is different. Some companies have a great knowledge and understanding of what that role is and other companies not so much. Trying to embed yourself into the organization can be quite challenging. So that was trying to navigate all the different companies and different needs of each company as a consultant and as a contract.

Speaker 2 8:42

Qpv has its own set of challenges, but working across different companies gives you that great insight into how different companies do things. That's really invaluable, I think some people. When you're working within a company for 10 to 20 years and you only know one way of doing things, it's quite hard then to break through that mould and to think of better ways or different ways to do things. So I think having worked as a consultant and seeing all of the different companies and how they do things, it does give you that great insight into better ways or different ways to do things. So I worked within Diamond for a number of years before they were acquired by Pro Pharma Group and then I went off and had a couple of babies and then since then I've been working again as a consultant. I set up Signal Pharma experts and I've been growing that with my partner, carly. We've been growing that business for the last couple of years now at this stage, which is great, and again working with different clients, seeing how people do things, being able to bring that insight and those questions to the client.

Speaker 2 10:03

So just challenging them about okay, why are you doing things this way? And there are different ways to do that. So just bringing those questions to the table and having those top provoking conversations with clients about okay, is that the most efficient way to do things? Is there a better way? Is there a more inefficient way? Is there a more efficient way to look at how you want to get where you're going? So I think, as a consultant, that's something that we always try to bring to the table is having those conversations. That can be difficult to have with a client because, as you know, that get used to doing things a particular way and to try and change people into going down a different route. Maybe that is ultimately get them to their goal quicker, but will require a change in the thought process. It can be challenging, but I do think that's the advantage of working with multiple different clients and seeing different ways of doing things for sure.

Speaker 1 11:11

Yeah, I think I can concur with all the things that you're saying there, especially the siloed approach. I quite like the fact that you're absolutely right. The larger companies are very, very siloed sometimes and, in weird ways, some of the silos are not necessarily the same from one company to the next. I do want to say so. We actually met at World Drug Safety Congress, europe and, let's not lie, there was one topic of conversation throughout the 11 streams that were there, which was AI. So do you think AI is the silver bullet for the smaller pharma companies or the smaller CROs?

AI Challenges in Small Companies

Speaker 2 11:56

It's a hard one because, yes, for sure, the Drug Safety Congress it was the buzzword. Everyone was talking about AI and I did come away from that conference thinking really don't think we tailored the conversation for smaller companies, for smaller CROs, for smaller service providers, if I felt that there definitely was scope for those conversations to be tailored to that audience in a lot more efficient ways. Having worked in companies where you are the PV department and you do everything, and having worked in service providers where you're working with clients who have limited resources internally and also potentially have constraints around expenditure and budget constraints to consider, it's hard to have those conversations about AI Because for them it's just not tangible or realistic to think about bolting on all of these weird and wonderful new technologies. It's just out of reach for a lot of companies. So it does make you think, ok, are there better ways to target these types of companies and for these kinds of companies to get involved and to utilize the power that AI and innovation and all of the innovation that we're seeing, but to do that in a more respectful way to the situation that we're talking about in terms of those companies and the resources that they have? And I don't know what the answer to that is.

Speaker 2 13:42

Potentially, I think we've had conversations, very theoretical conversations, around small companies, kind of joining forces together and thinking about ways in which they can make efficiencies. So a lot of the big service providers in terms of safety databases there have amazing technologies to offer, but a lot of that AI technology is driven by volume. So you need the volume of cases, you need the volume of data coming through to make that a sound option for you, and small companies with one molecule maybe to their portfolio just don't have that availability in terms of data. So what about small companies forming some form of a co-op, like you know, banding together, having and utilizing the power of numbers in terms of multiple different clients coming together, joining forces, banding together and approaching one of the big safety database vendors to put something together for them? I don't know if that's. I know there's going to be, there's going to be constraints around data protection and all the rest of it. That would need to be considered for sure. But at the moment it's just the clients that I work with in the majority are small biotech with, you know, one, two products to their portfolio. We don't even have the conversation about AI, because it's just it's not. It's not relevant, it's not doable and it's not something that's attainable for them at the moment.

Speaker 2 15:31

So I do feel that these conversations around AI, we're kind of focusing that at a group of maybe five to 10 companies who for them it's one it's necessary, but two it's attainable and three it's going to make a difference in terms of how they do their day to day. But there's hundreds and thousands of companies outside of that sphere where we're doing the day to day grind and still companies are existing with Excel spreadsheets and you know very manual processes and for them innovation isn't AI. Or you know really high tech solutions that can be bolted onto the safety database. Innovation is OK. What can you do for me that will make my process more efficient? What can you do in terms of looking at my vendors that I'm utilizing? What can you do in terms of processes that we're using internally and externally that can be improved upon? And that's innovation. It's not necessarily this. You know really high tech world that for most people it's not going to be something that they're going to be dipping their toe into anytime soon.

Speaker 1 16:54

I think your co-op idea is absolutely magnificent and actually your point about the fact that these companies can't even think about AI at the moment. They're more worried about the normal day to day issues. And a question that comes up in my head is how do the smaller farmer react to regulatory inspections, especially when it's the first, maybe the first, marketed product or they're just about to go into market? How do they feel about these regulators who come in with their, with their view on that singular products that they have?

Speaker 2 17:40

But for, I mean, most companies are very fearful of an inspection. That's dread, you know. And one thing that we as consultants talk to clients about is inspection ready. You know inspection ready, need to be inspection ready. So you're kind of drilling into them from the very get. Go that, ok, everything you do you need to be thinking about OK, if I was inspected tomorrow, how would I defend this decision? If I was inspected tomorrow, how would I explain X, y and Z?

Speaker 2 18:13

But it's, it's that that's the nature of the, I guess, the world that we're living in. It's a very regulated industry. When we move to, moving from clinical into post-marketing, you know there's going to be an inspection from. You know, pre FDA submission, pre EMA submission, you're going to have an inspection. So the companies are aware of that. But it's it's trying to, I guess not we want people to be have a some level of anxiety around an inspection, because that's what makes people, you know, keeps people on their toes, but at the same time you don't want people to be so fearful that you know it becomes overwhelming for them. But trying to strike that balance of, ok, just thinking about it rationally and logically, and everything that you do, it needs to be documented and you need to be thinking about OK, how can I explain this? So planning, project planning, documentation, it's the same thing and it's just repeat, repeat, repeat and making sure that you're kind of drilling that home and also the other, the other.

Speaker 2 19:26

I think one of the other main areas that we need to kind of work on and this goes across the board for any client is trying to get those connections between the different groups within an organization.

Speaker 2 19:40

So PV, yes, we're one group, but we work heavily with regulatory affairs and with quality and with other departments within the organization and we all need to be on the same page. So everyone is trying to get to the same end point. We're all working toward the same objectives. But I think that can, that can break down sometimes within companies and there can be some kind of underlying level of competition between departments.

Speaker 2 20:09

So it's always something that I try to do as a consultant when I go into a company is to try and faster that I think you know team spirit among the different departments and make sure that we are all aligned with our goals and with OK, the strategy to achieve those goals, because it can be so much time wasted with inefficiencies because one department is doing something and another department is doing something quite similar but not exactly the same thing. So trying to have those conversations and, you know, holistic view of the company and the company goals Can really help. And that can help when you come to inspection time as well, because everyone's aware of what everyone else is doing and it makes it easier to navigate those situations.

Speaker 1 20:59

As the Covid 19 pandemic, being able to give a case to some of the smaller companies from a PV department perspective, to say that PV needs to be a little bit more forefront in some of these novel, novel medicines that they're, that they're discovering or coming out of, clinical, as it were.

Speaker 2 21:29

And I'm not. I'm not sure, to be honest. I don't know that there's been a huge change in that kind of mindset. I know I don't. I wouldn't say there's been a huge impact that I have seen.

Speaker 1 21:52

Anyway, and going back to another thing that I was thinking about. Thinking about your career, you'd obviously move from clinical on the clinical side and post marketed side. If you were to explain to someone the difference between the two from a from a work perspective, not, not, not the regulation perspective, but what is the difference? What do you think is not harder per se, but what do you think is more difficult in each of those sides?

Speaker 2 22:28

Yeah, and I think this is this is something that is often a struggle when we move into preparing a company to put their application in is trying to get that switch between okay, this is clinical, and this is what we're going to be doing with post marketing and post marketing PV especially. I'm talking about I'll just focus on Europe for the minute and there's a lot more regulations, legislations, it's, it's a lot. So we've all of the GVP modules, obviously within Europe, and there's just a lot more activities. So we've, we've, we've a ton of activities that need to be done for post marketing, pv, and clinical does less in terms of activities. We really only have kind of case processing, susars, dsu, or and then you've got, you know, some signal detection and stuff going on in the periphery, but there's not a huge amount of activities, whereas with post marketing, we have a lot more. So we've all of the different GVP modules and all of the different requirements. With the PSMF, we've a QPV, we've got, you know, signal detection, rmps, all of the other activities that need to be done, and and and managed, and you're dealing with real world data and whatever that means. So, yes, you've people taking the product in ways that, with your clinical trials. You've a very defined protocol. You've a very defined way of the product being administered. You have exclusion inclusion criteria.

Speaker 2 24:05

When you move into post marketing, you've got people taking it willy nilly. No, obviously you have an SMPC and you have contraindications and you have all of the rest. But it's a lot looser in terms of the framework around it. So GCP and GCP regulations and all the ICHs were very prescriptive. It's very, very prescriptive. Post marketing. We have the GVP modules around the processes that we need to do, but how the drug is taken and how the drug is administered and how people and who's taking it, that's a lot looser.

Speaker 2 24:42

So the data that we start to see coming in really can be quite different from what we've seen in clinical trials. And it's trying to navigate that and we need to. I guess it's not as defined in terms of how we would. We were doing things with GCP, so we would have our interim analysis, we'd have our DS and Bs. When we move to post marketing, it's a little bit freer. We have signal detection, obviously, and we've tried our safety reports. But the data that you get coming through can really throw up some surprises, because we're using it in a way that we didn't see when we used it in clinical trials. So yeah, differences in terms of how the products use and also in terms of the activities. We've a lot more activities to do with post marketing.

Speaker 1 25:32

And also I was just thinking about you being a QPPV for several companies, several being the word that I was focusing on.

Speaker 2 25:44

My great in my other life, not now.

Speaker 1 25:48

But I remember when I started PV and I don't know if I got a lecture, but I'm fairly sure it was a lecture where I was told the QPPV is the most important person in the world, because if the safety isn't done correctly and you don't do your job correctly they are going to jail. And that was pretty much the first, one of the first conversations, I think I'd had in PV. Do you think it still has that sort of sense of you know what you do is related to this person's future?

Speaker 2 26:30

The weight of responsibility of a QPPV. It is a weighty role and there's a lot to it and I think it's really important that the QPPV educates the MAH, so the client. If you're within the organization, it's a little bit easier, but if you're an external consultant QPPV, it is your role to educate that client about what it is you're doing, how you're doing it, what their responsibilities are to you, what your responsibilities are to them. And ultimately, it really is about that educational piece, because a lot of people don't know what it is, especially if you're more so if you're dealing with a US company that this is their first time putting in a product application they haven't dealt in Europe before. So it is very much an educational role that you go on and it is about okay, this is what I want to see. These are the conversations I need to be in, these are the decisions I need to be part of. And the commercial.

Speaker 2 27:39

Usually one of the most difficult areas to break into as a QPPV is the commercial side of things. So regulatory affairs they get it. Quality, get it and all of the other ancillary functions will get it. Commercial either don't get it or they don't want to get it. So they're the real, they're the troublesome piece, because often we have commercial people going off and looking for new products to acquire, looking for assets, thinking about all of those lovely commercial decisions that they're going to make to bring assets in, and they don't think about PV, they certainly don't think about the QPPV.

Speaker 2 28:21

So having those conversations literally banging that drum from the first time you are appointed QPPV and trying to break through into that commercial conversation to say, look, if you are acquiring an asset, you need to do due diligence. Part of that due diligence involves me looking at that asset and assessing it in terms of a PV, from a PV point of view, to see if it's going to be a pain in the neck for not only for me but for everyone in this company. And I've been burned in the past with not being involved in those conversations and the company therefore has been burned because they've acquired an asset that's been an absolute ball ache, to put it frankly, and costly in terms of extra safety and costly in terms of just the huge amount of additional or MMS and additional minimization measures that we have to take because of this product. And you know they learned their lessons at that point, trying to educate them before that kind of decision is made is really hard to do sometimes.

Speaker 1 29:37

Does safety ever get involved at the commercial conversation, at the point I mean, have you ever seen this happen where they are actually fully well involved with the commercial buying procedure or whatever assets that they're going to, that they're thinking of buying, and how has it worked?

Speaker 2 29:57

So, yeah, we, we have been involved and I think a lot of companies.

Speaker 2 30:01

When you explain to them that exact reason why we need to involve in the conversation, they're quite open to it. Then and they, we've, we've done due diligence reports for assets out and, having reviewed that due diligence report, commercial has said no, we don't, we won't go any further with that and prospects. So yeah it. I we've had clients in the past that have been really good and really proactive and really get us involved quite early on in that, in that commercial piece where they're looking at assets to acquire. But again, it is about just educating, informing them, telling them, okay, this is what could happen if you don't. But often you know those receptive commercial people out there I'm not going to bash the commercial people, because it's lovely people that work in commercial, but those, those commercial people that like PV and understand what it is that we're trying to do, will really get on board with it and include us in those conversations quite early on and listen to what we're saying to them, which is the main thing listening.

Speaker 2 31:10

Yes, listening.

Speaker 1 31:12

Yeah, not just providing free pens when we're going with this.

Speaker 2 31:18

Um Other way. I will take free pens.

Speaker 1 31:22

I will take free pens all day. I don't even know where my pens end up after the day, um, so it's really interesting. You've had a fascinating career and you currently I mean, it's fascinating to me, I think, to be QPPV of so many or some or several small companies is something that I don't think I would ever, ever do, not because of my uh, my uh, educational limits, but more to do with the fear of being a QP. Um, these small farmers, these novel innovators let's call them innovators what have you seen in the past couple of years? That has been the same issue at every single company.

Challenges and Considerations in Post-Marketing Activities

Speaker 2 32:22

Yeah, um, I think, to be honest, it is that transition from clinical into thinking about post marketing and what that entails. Um, there's a lot of setup that needs to be done, so there's a lot of infrastructure that we need to put in place to achieve a compliance system in terms of post marketing. There's a lot of work that needs to happen, um, you need to have a really good understanding of the company and what they've done in the past, how they operate, who does what? Um, and you have to have that buy in from all of those different departments to to achieve what you want to achieve in terms of setting up. I find that, within companies, it is that, um, trying to gauge who's doing what within each department and and having those departments come together is quite challenging. Um, I think when, when a company is in a clinical setting, it's it's very much clear who's doing what. You figure cleanups, who do cleanups, regulates, you do what they do. When you move to post marketing, pv, there is interdependencies between each of those departments and there's other things that need to be considered. We need to think about vendor management. We need to think about auditing. We need to think about who's in our audit universe. We need to think about where we're going to get information for our PSMF. So who's going to be providing that? Kpis compliance and I'm not saying that we don't have any of those metrics compliance vendor management with clinical, but we have a lot more of it. When we move into post marketing, we need to have that interlink with commercial to figure out, okay, when we have an approval, what, who you set partnerships with for distribution, for manufacturing, for what about licensed partners? Who's going to hold MAH in each territory? So there's just a lot more to think of and it's bringing, I think, those departments on that journey that can be quite challenging and getting that link up in terms of, okay, this is what I need from you, this is what you need to be doing. I'm going to be setting up the PV stuff, but are you think what about reg affairs? What are they doing for, for you know, their variation, submission? Are they thinking about CCDS process? All of that has to happen as well. Quality needs to consider additional vendors that are coming into the, into the universe. Auditing how are we, how are we auditing change controls? Who's managing the changes around all of these activities? The QMS has that been, you know? Is that robust enough to cover all of this, and I think that's that's been. That's always been.

Speaker 2 35:01

The challenge is trying to get those departments to come with you at the right time. It's not that there's reluctance, I just think everyone's so busy, especially when you're coming up to the end of a trial. People are focused on that, and rightly so. Like you know, they're focused on getting that data cleaned, looking at the readouts and doing all of the stuff that they've been doing all along. You're trying to tell them I need SOPs on a PSMF in 12 months. They're like, yeah, okay, I don't care, so it's it. That's. That's kind of the third part. And you get, you do get buy-in, but you only get it for so long.

Speaker 2 35:46

I think people get fatigued when you're you're coming with your cap and hand, looking for more of their time to achieve your goals.

Speaker 2 35:55

I think that's a natural human thing. I don't think that's I don't think that's specific to pharma is that people have, you know, a certain bandwidth for for buying into things and that expires after a certain amount of time. So what do you do after that? That's where you need to generate a little bit more umph and a bit more motivation and a bit more interest in what you're doing and I think people need to know what the ultimate goal is and to feel like they're part of that. I think people need to be able to buy into something. So if you're putting any kind of change, people are reluctant to change, but if they feel like they've been part of the process, they're more likely to go along with that change. So it's having those conversations, making sure everyone knows what you're doing, making sure everyone knows what your ultimate goals are and how that aligns with other department's goals and the overall company goals, will help. Don't operate don't operate in a silo and think that people are going to come along on the journey, because it just won't happen.

Speaker 1 37:02

Is there an ideal time to bring these people in uh into your journey?

Speaker 2 37:08

As soon as possible. I think the minute your face appears in an organization, it's like you're a politician. You're going on that campaign of knocking on doors and looking for a vote. That's the way I kind of think about it. Is okay, I'm the new politician in town. I need to get these people to vote for me. So I'm going to knock on their door and I'm going to educate them as to what I'm doing and tell them how I'm going to try and achieve that and hopefully then, when they see my name appear on emails and they see my name appear in different conversations, they can connect the dots and realize okay, I understand what we're trying to do here. I'm not just annoying these people for the sake of it. Believe it or not, I can be very annoying.

Speaker 1 37:59

Never, never, never annoying. Risk minimization you were talking about that earlier and actually there was another thought I had about real world data, but I don't want to call it fashionable. But there is a big move from the big players to have risk management departments and they're putting significant amounts of resources into this risk management whole departments From a again from a small farmer perspective.

Speaker 2 38:48

Imagine having an apartment for risk management, imagine having a QPBB office. Imagine all of those wondrous things. Yeah, it's a different world. I think we don't have risk management departments in smaller companies. Again, it defaults to the QPBB, obviously has oversight over your risk management plan and your minimization activities, but it feeds downward into all of the other activities that you're working across. So I think it's crucial that your signal detection process is robust and is really thinking about those risk management activities every time you do signal detection.

Speaker 2 39:31

So don't come to write a PSU war and then you're looking at the RMP and going, oh, what are our risks and what are our RMMs and what do we need to do here? It really needs to be something that's part of the frequent PV operational tasks, but, again, it needs to drip feed all the way down to case processors being aware, having that mindfulness in terms of what are the risks, what are we looking at. Is this something that we need to be flagging? But it's not a luxury that most companies have in terms of having a focused department. It really comes to trying to carve out additional time, additional periods of focus within your day-to-day operational tasks to look at those risk minimization measures.

Speaker 1 40:29

And I was thinking about real world data and I was thinking about, again, thinking about the big boys, the big farmers, and I was thinking about how the move is to go into big data, to essentially look at all the data throughout their company and to start doing potential PV on all the data that they can find. How would that work?

Speaker 2 40:59

How would that work in a smaller company?

Speaker 1 41:01

In a smaller company.

Speaker 2 41:02

yeah, I mean, I don't know, You'd have to have a human being trawling through all of these different mediums manually at the moment because there just isn't any other. There isn't scope for any other technological tools to do that. So it's the scary one, because at the minute everyone's kind of skirting around the issue. Nobody's really tapping into that source of data. But the minute we start to do it, when someone starts to do it, then there's this domino effect of other people falling in line to do it. And then what happens? We need to have some kind of legislation around how we're doing that, and the worry is that it could become stragged into. It becomes legislation and then we're all having to do this without actually knowing how to do it.

Speaker 2 41:51

So if we get down the road to another pilot for signal management. That goes on for 10 years and nobody ever actually ends the pilot. Yeah, I don't know. I don't know how that would be done. It's a terrifying thought to think about having to actually go and mine that information without any parameters around that. So it's again. It's a free-for-all. Everyone's going to do it, however they think it needs to be done. There's no defined way to do it, and then the quality of data that you get out of it again is going to be questionable. How do you do the follow-up? What is this data bringing to the table? Yeah, it's a bit of a minefield.

Speaker 1 42:43

I think it's.

Speaker 2 42:43

I don't want to touch this.

Speaker 1 42:48

The reason I brought that up. I was thinking about IDMP and the original IDMP idea and the amount of different variables from the data that we could have possibly have received through the NPCs and all the other different layers that they had in IDMP, and I can only imagine being in a small farmer seeing that original guidance coming out I think that was back in 2012-ish, 2013-ish, I think, maybe it was before then and just being terrified that this new legislation just came. And how do we deal with this? Obviously it hasn't quite come out the way in time and, secondly, in the way that it was originally thought out.

Speaker 1 43:42

But I guess what I'm trying to get at is these regulation changes which tend to come from the fact that someone has done something in a company and the regulators have said oh no, we need to make sure that there is a standardized way of doing this, just like you were saying, and then it's down to the smaller companies who, like you said there's so many of them then have to implement this change very fast and very quickly.

Speaker 2 44:14

Yeah, and it's again.

Speaker 2 44:16

We're skewing.

Speaker 2 44:18

I think in some ways we're skewing PV to suit the bigger players.

Speaker 2 44:26

I think, and the conversations that we're hearing the most about and the most chatter about are from those bigger organizations who have the resources, who have the time, who have the manforce to think about this, to think about oh, let's go and look at real world data.

Speaker 2 44:49

I think a lot of small companies, most small companies, are thinking about it and if they are thinking about it, they're thinking, oh my God, how are we going to implement this in a semi-compliant manner, in a manner in which we can stand over it if we're questioned in an inspection? So at the moment, I don't know the answer in terms of how that would look, but I do think that, for sure, the conversations that we're having are definitely skewing to those companies who are in a better position to deal with these types of advancements and have the luxury of that ability to even have these conversations, and to the detriment, in some ways, of those smaller companies who will have to row in behind these changes when they do happen and deal with it with minimum resources and often very manual ways of implementing these technological advancements.

Speaker 1 45:59

So the name of this podcast is Innovation and the Future of Pharma Coffidgeness. So the question is what's next for PV in the next five years, the next two years? Where do you see small pharma being? Obviously, there's this. There is a I suppose it's always a tendency of the bigger guys coming to swallow up some of the smaller ones with novel drugs that they particularly like or have commercial success. But what do you think is required for these smaller pharma companies to be able to push forward and be innovative with regards to PV?

Speaker 2 46:56

I think we're talking about innovation and the technological advancements. In some ways, I think we've gone too far down the road. We need to drag it back and simplify things a little bit, because when you think of all of these technological advancements the likes of RSG, argus, all of the big safety database vendors even with these additional tools, they're having to create customizations for each of these big clients, because everyone has their own way of doing things and nobody wants to give up the way that they've been doing things for the last 10 years. In a way, I'd like to see everything. Let's scale it back a little bit. Let's make things a little bit more simplified. We have legislation that we need to work to, we have GVP and we have other jurisdictions that exist, but in terms of Europe, we have GVPs and we know what the requirements are.

Speaker 2 47:59

Why have we gone down the road of making everything so complicated? Why have we so many different workarounds, work streams, modifications to the way in which we're doing things? And I think when you're a small company in a small innovator sphere, in a way, you have the luxury of being able to simplify things, and that's what I would always advocate is let's not overcomplicate this. What are the requirements that we have in terms of legislation, in terms of what do we need to do to be compliant? Why are we going to complicate that by adding on this, that and the other, making all of these different modifications, customizing all of these different reports, doing this, that and the other, when really, all we need to do is X, y and Z? I do think we've nearly over-egged the pudding with adding on all of these bells and whistles, and I get the point. When you have huge volumes of data coming through, you need to think of smarter and more innovative ways to look at that data. But for the smaller companies, for sure, it is an opportunity to just streamline how we're doing things. Let's not, in a way, worry too much about AI and about all of these weird and wonderful technological advancements right now, because we don't need to worry about it right now.

Speaker 2 49:21

Our data doesn't require all of that. What we need to do is X, y and Z. We need to get the data, we need to put the data in a safety database, we need to look at that data and we need to make sure that we're keeping on top of that safety profile in a compliant manner. And that's really it and I think, having those conversations with clients.

Speaker 2 49:40

Sometimes I think PVP people are guilty of over-complicating everything. Quoting PVP yes, we need to know what's in those PVP modules, but we need to ensure we're compliant. At the end of the day, that's the most important thing we're doing things in a compliant manner. That doesn't mean it has to be a complicated manner, so I think that's one luxury and one of the upsides of working in small farmers is that you don't have to worry about all of this technological stuff that we need to worry about. We don't need to worry about all of these AI add-ons that we need to do to speed up our process, because we just don't have that volume and we don't need to do that. There's other ways to be efficient without using AI.

Speaker 1 50:34

Atherin, it's been an absolute pleasure having you here today. Thank you very much for joining.

Speaker 2 50:40

Thanks, Cindy, See you lovely.